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Hydrocortisone - Generic Drug Details
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What are the generic sources for hydrocortisone and what is the scope of freedom to operate?
Hydrocortisone
is the generic ingredient in seventy-five branded drugs marketed by Allergan Herbert, Crown Labs, Salix Pharms, Bayer Pharms, Monarch Pharms, Valeant Pharm Intl, Westwood Squibb, Pharm Assoc, C And M Pharma, Actavis Mid Atlantic, Alpharma Us Pharms, Altana, Ambix, Everylife, Fougera Pharms Inc, G And W Labs, Ingram Pharm, Ivax Pharms, Lannett Co Inc, Naska, Perrigo New York, Pharmaderm, Pharmafair, Rising, Stiefel, Syosset, Taro, Taro Pharm Inds Ltd, Teligent Pharma Inc, Teva, Topiderm, Usl Pharma, Whiteworth Town Plsn, Valeant Intl, Bausch, Medicis, Paddock Llc, Ani Pharms, Teva Pharms, Healthpoint, Pharmacia And Upjohn, Baker Norton, Solvay, Beta Dermac, Bluline, Heran, Fougera Pharms, Mericon, Dow Pharm, Perrigo Co, Pfizer Global, Cmp Pharma Inc, Dermik Labs, Torch, X Gen Pharms, Mission Pharma, Pfizer, Barr, Breckenridge, Elkins Sinn, Ferrante, Hikma Intl Pharms, Impax Labs, Impax Labs Inc, Inwood Labs, Lannett, Nexgen Pharma Inc, Panray, Parke Davis, Purepac Pharm, Roxane, Sandoz, Vintage, Watson Labs, Merck, Pfipharmecs, Mylan Speciality Lp, Able, Cenci, Ferndale Labs, Sebela Ireland Ltd, Akorn, Bel Mar, Fera Pharms, Colgate, Genus Lifesciences, Glenmark Generics, Taro Pharm Inds, Yamanouchi, Precision Dermat, Lupin Ltd, Abbott, Hospira, Abraxis Pharm, Baxter Hlthcare, Intl Medication, Acp Nimble, Glenmark Pharms Ltd, Perrigo Israel, Sun Pharm Inds Inc, Amring Pharms, Bausch And Lomb, Sandoz Inc, Casper Pharma Llc, Schering, Actavis Labs Fl Inc, Forest Labs, Lederle, and Bioglan, and is included in two hundred and fifty-three NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are sixty-seven drug master file entries for hydrocortisone. Thirty-three suppliers are listed for this compound.
Summary for hydrocortisone
US Patents: | 2 |
Tradenames: | 75 |
Applicants: | 109 |
NDAs: | 253 |
Drug Master File Entries: | 67 |
Suppliers / Packagers: | 33 |
Bulk Api Vendors: | 89 |
Clinical Trials: | 331 |
Patent Applications: | 7,164 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for hydrocortisone |
Drug Sales Revenues: | Drug sales revenues for hydrocortisone |
DailyMed Link: | hydrocortisone at DailyMed |
Recent Clinical Trials for hydrocortisone
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Tehran University of Medical Sciences | Phase 3 |
Salah Eldeen Ibrahim Alsherif | N/A |
Mohamed Mohi El deen Abo El yazeed | N/A |
Pharmacology for hydrocortisone
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for hydrocortisone
Synonyms for hydrocortisone
(11alpha,14beta)-11,17,21-Trihydroxypregn-4-Ene-3,20-Dione |
(11beta)-11,17,21-Trihydroxy-pregn-4-ene-3,20-dione |
(11beta)-11,17,21-trihydroxypregn-4-ene-3,20-dione |
(1S,10S,11S,15S,17S,2R,14R)-14,17-dihydroxy-14-(2-hydroxyacetyl)-2,15-dimethyl tetracyclo[8.7.0.0<2,7>.0<11,15>]heptadec-6-en-5-one |
(1S,2R,10S,11S,14R,15S,17S)-14,17-dihydroxy-14-(2-hydroxyacetyl)-2,15-dimethyltetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-6-en-5-one |
(1S,2R,10S,11S,14R,15S,17S)-14,17-dihydroxy-14-(2-hydroxyacetyl)-2,15-dimethyltetracyclo[8.7.0.0(2),.0(1)(1),(1)]heptadec-6-en-5-one |
(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-3H-cyclopenta[a]phenanthren-3-one |
(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-3-one |
(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-3(2H)-one |
(8xi,9xi,11beta,14xi)-11,17,21-trihydroxypregn-4-ene-3,20-dione |
[3H]cortisol |
1050676-88-4 |
11-beta-Hydrocortisone |
11-beta-Hydroxycortisone |
11-Hydrocortisone |
11,17,21-Trihydroxypregn-4-ene-3,20-dione, (11.beta.)- |
11?,17?,21-Trihydroxypregn-4-ene-3,20-dione |
11.beta.-Hydrocortisone |
11.beta.-Hydroxycortisone |
11.beta.,17,21-Trihydroxypregn-4-ene-3,20-dione |
11.beta.,17,21-trihydroxyprogesterone |
11.beta.,17.alpha.,21-Trihydroxy-4-pregnene-3,20-dione |
11.beta.,17.alpha.,21-Trihydroxypregn-4-ene-3,20-dione |
11|A,17|A,21-Trihydroxypregn-4-ene-3,20-dione; 17-Hydroxycorticosterone; 4-Pregnene-11|A,17|A,21-triol-3,20-dione; Cortisol; Kendall inverted exclamation mark s compound F; Reichstein inverted exclamation mark s substance M |
11a-Hydroxycorticosterone |
11alpha-Hydroxycorticosterone |
11b-Hydrocortisone |
11b-Hydroxycortisone |
11b,17,21-Trihydroxyprogesterone |
11beta-cortisol |
11beta-Hydrocortisone |
11beta-Hydroxycortisone |
11beta,17,21-Trihydroxypregn-4-ene-3,20-dione |
11beta,17,21-Trihydroxyprogesterone |
11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione |
11beta,17alpha,21-Trihydroxypregn-4-ene-3,20-dione |
1436392-18-5 |
17-Hydroxycorticosterone |
17.alpha.-Hydroxycorticosterone |
17a-Hydroxycorticosterone |
17alpha-Hydroxycorticosterone |
2v95 |
3h-cortisol |
4-(6-chloro-4-oxoquinazolin-3(4H)-yl)-N-(3-methoxyphenyl)piperidine-1-carboxamide |
4-Pregnen-11.beta.,17.alpha.,21-triol-3,20-dione |
4-Pregnen-11beta,17alpha,21-triol-3,20-dione |
4-Pregnene-11.beta.,17.alpha.,21-triol-3,20-dione |
4-Pregnene-11alpha,21-triol 3,20-dione |
4-Pregnene-11b,17a,21-triol-3,20-dione |
4-Pregnene-11beta,17alpha,21-triol-3,20-dione |
4p6x |
50-23-7 |
50H237 |
6861-EP2269977A2 |
6861-EP2270008A1 |
6861-EP2277565A2 |
6861-EP2277566A2 |
6861-EP2277567A1 |
6861-EP2277568A2 |
6861-EP2277569A2 |
6861-EP2277570A2 |
6861-EP2292227A2 |
6861-EP2292280A1 |
6861-EP2292615A1 |
6861-EP2292617A1 |
6861-EP2295409A1 |
6861-EP2298778A1 |
6861-EP2305679A1 |
6861-EP2308562A2 |
6861-EP2314590A1 |
6861-EP2371811A2 |
7062-EP2269977A2 |
7062-EP2292228A1 |
7062-EP2295411A1 |
7062-EP2298747A1 |
7062-EP2301931A1 |
7062-EP2308851A1 |
7062-EP2308880A1 |
7062-EP2311811A1 |
7062-EP2314585A1 |
8056-08-4 |
80562-38-5 |
8063-42-1 |
92372-EP2280008A2 |
92372-EP2289483A1 |
92372-EP2305257A1 |
AB1009452 |
AC-12902 |
AC1L1L2B |
ACETIC ACID W/ HYDROCORTISONE |
Acticort |
Acticort (TN) |
Aeroseb HC |
Aeroseb-HC |
AI3-25006 |
AJ-64104 |
AKOS001582651 |
Ala-Cort |
Ala-Scalp |
Alacort |
Algicirtis |
Alphaderm |
Alphaderm (Salt/Mix) |
Amberin |
AN-24370 |
Anflam |
Anti-inflammatory hormone |
Anucort |
Anucort-HC |
Anusol HC |
Anusol HC (TN) |
Aquacort |
Aquanil HC |
AS-11651 |
B1951 |
B48448A1-24BA-47CA-8D9E-43E5BC949386 |
Balneol-hc |
Barseb HC |
Basan-Corti |
BCP09054 |
BDBM13775 |
Beta-hc |
BP-20390 |
BPBio1_000544 |
BRD-K93568044-001-03-1 |
BRD-K93568044-001-11-4 |
BRD-K93568044-001-32-0 |
BSPBio_000494 |
C00735 |
CaldeCORT Spray |
CALMURID HC |
CAS-50-23-7 |
CCG-204683 |
CCRIS 5854 |
Cetacort |
CHEBI:17650 |
CHEMBL389621 |
Chronocort |
Clear aid |
Cleiton |
Cobadex |
Colocort |
Colocort (TN) |
component of Lubricort |
component of Neo-Cort-Dome |
component of Otalgine |
Compound F |
Compound F (kendall) |
COR-OTICIN |
Corhydron |
Cort-Dome |
Cort-Quin (Salt/Mix) |
Cortanal |
Cortef |
Cortef (TN) |
Cortenema |
Cortesal |
Corticreme |
Cortifair |
Cortifan |
Cortiment |
Cortisol |
Cortisol alcohol |
Cortisol solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material |
Cortisolonum |
Cortisporin |
Cortisporin (Salt/Mix) |
Cortisporin Otico |
Cortispray |
Cortizol |
Cortolotion |
Cortonema |
Cortoxide |
Cortril |
CPD000653523 |
Cremesone |
Cremicort-H |
CS-2226 |
CTK8F3227 |
Cutisol |
D00088 |
DB00741 |
Delacort |
Derm-Aid |
Dermacort |
Dermaspray |
Dermil |
Dermocortal |
Dermolate |
Dihydrocostisone |
Dioderm |
Dome-cort |
Domolene-HC |
Drotic |
Drotic (Salt/Mix) |
DSSTox_CID_714 |
DSSTox_GSID_20714 |
DSSTox_RID_75753 |
DTXSID7020714 |
DuoCort |
EC 200-020-1 |
Ef corlin |
Efcorbin |
Efcortelan |
Efcortelin |
EINECS 200-020-1 |
Eldecort |
Eldercort |
Epicort |
Epicortisol |
Epiderm H |
Epitope ID:174851 |
Esiderm H |
EU-0100594 |
Evacort |
Ficortril |
Fiocortril |
Flexicort |
Foille Insetti |
Genacort |
Genacort (lotion) |
Glycort |
GTPL2868 |
Gyno-Cortisone |
H 4001 |
H-Cort |
HC |
HC (HYDROCORTISONE) |
HC #1 |
HC #4 |
Heb Cort |
Heb-Cort |
Hi-cor |
Hidalone |
Hidro-Colisona |
Hidrocortisona |
Hidrocortisona [INN-Spanish] |
HMS1569I16 |
HMS2090M04 |
HMS2096I16 |
HMS2230B18 |
HMS2235F17 |
HMS3259C05 |
HMS3261H10 |
HMS3713I16 |
HSDB 3339 |
HY-N0583 |
Hycort |
Hycortol |
Hycortole |
Hydracort |
Hydrasson |
Hydro-Adreson |
Hydro-Colisona |
Hydro-RX |
Hydrocort |
Hydrocortal |
Hydrocorticosterone |
Hydrocortisone (Cortisol) |
Hydrocortisone (JP17/USP/INN) |
Hydrocortisone [INN:BAN:JAN] |
Hydrocortisone [USP:INN:BAN:JAN] |
Hydrocortisone alcohol |
Hydrocortisone base |
Hydrocortisone for peak identification, European Pharmacopoeia (EP) Reference Standard |
Hydrocortisone free alcohol |
HYDROCORTISONE IN ABSORBASE |
Hydrocortisone solution, 50 muM, sterile-filtered, BioXtra, suitable for cell culture |
Hydrocortisone-Water Soluble, BioReagent, suitable for cell culture |
Hydrocortisone, >=98% (HPLC) |
Hydrocortisone, 98% |
Hydrocortisone, BioReagent, suitable for cell culture |
Hydrocortisone, British Pharmacopoeia (BP) Assay Standard |
Hydrocortisone, European Pharmacopoeia (EP) Reference Standard |
Hydrocortisone, gamma-irradiated, powder, BioXtra, suitable for cell culture |
Hydrocortisone, meets USP testing specifications |
Hydrocortisone, Pharmaceutical Secondary Standard; Certified Reference Material |
Hydrocortisone, topical |
Hydrocortisone, United States Pharmacopeia (USP) Reference Standard |
Hydrocortisone, VETRANAL(TM), analytical standard |
Hydrocortisonum |
Hydrocortisonum [INN-Latin] |
Hydrocortisyl |
Hydrocortone |
Hydroskin |
Hydroxycortisone |
Hysone |
Hytisone |
Hytone |
Hytone (TN) |
Hytone lotion |
Idrocortisone |
Idrocortisone [DCIT] |
Incortin-H |
Incortin-hydrogen |
J10114 |
JYGXADMDTFJGBT-VWUMJDOOSA-N |
Kendall's compound F |
Kendalls compound F |
Komed HC |
Kyypakkaus |
Lacticare HC |
Lacticare-HC |
Lactisona |
LMST02030001 |
Lopac0_000594 |
LP00594 |
LS-7439 |
Lubricort |
Maintasone |
MCULE-8953627920 |
Medicort |
Meusicort |
MFCD00011654 |
Mildison |
Milliderm |
MLS000069609 |
MLS001148103 |
MLS002207135 |
MLS002222189 |
MLS002548868 |
MolPort-001-794-637 |
NC00456 |
NCGC00022848-06 |
NCGC00022848-07 |
NCGC00022848-09 |
NCGC00022848-10 |
NCGC00022848-11 |
NCGC00022848-12 |
NCGC00022848-13 |
NCGC00022848-14 |
NCGC00022848-15 |
NCGC00022848-17 |
NCGC00258369-01 |
NCGC00261279-01 |
NCI60_000118 |
Neo-Cort-Dome |
Neo-Cort-Dome (Salt/Mix) |
Neo-Cortef |
Neosporin-H Ear |
Nogenic HC |
NSC 10483 |
NSC-10483 |
NSC10483 |
Nutracort |
Nystaform-HC |
Opera_ID_1292 |
Optef |
Otalgine |
Otalgine (Salt/Mix) |
Otic-Neo-Cort-Dome |
Otic-Neo-Cort-Dome (Salt/Mix) |
Otobiotic |
Otobiotic (Salt/Mix) |
Otocort |
Otocort (Salt/Mix) |
Otosone-F |
Pediotic Suspension |
Pediotic Suspension (Salt/Mix) |
Penecort |
Permicort |
Plenadren |
Plenadren (TN) |
Polcort H |
Pregn-4-ene-3, 11,17,21-trihydroxy-, (11.beta.)- |
Pregn-4-ene-3, 11.beta.,17,21-trihydroxy- |
Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11-beta)- |
Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11.beta.)- |
Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11b)- |
Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)- |
Pregn-4-ene-3,20-dione, 11.beta.,17,21-trihydroxy- |
Pregn-4-ene-3,20-dione, 11beta,17,21-trihydroxy- |
Preparation H Hydrocortisone Cream |
Prepcort |
Prestwick_265 |
Prestwick0_000447 |
Prestwick1_000447 |
Prestwick2_000447 |
Prestwick3_000447 |
Prevex HC |
Proctocort |
Proctofoam |
Proctosol-HC |
Proctozone HC |
Protocort |
Q-201211 |
Racet |
Rectasol-HC |
Rectoid |
Reichstein's substance M |
Reichsteins substance M |
Remederm HC |
s1696 |
SAM002264617 |
Sanatison |
SBB012589 |
SC-18577 |
Scalp-Cort |
Scalpicin Capilar |
SCHEMBL4148 |
Schericur |
Scheroson F |
Sigmacort |
Signef |
SMP1_000156 |
SMR000059022 |
SMR000653523 |
SPBio_002433 |
SR-01000000139 |
SR-01000000139-3 |
ST069286 |
Stie-cort |
Stiefcorcil |
Synacort |
Systral Hydrocort |
Tarcortin |
Terra-cortril |
Texacort |
Texacort lotion 25 |
Timocort |
Tox21_110883 |
Tox21_110883_1 |
Tox21_200815 |
Tox21_500594 |
Transderma H |
Traumaide |
U 1851 |
Uniderm |
UNII-WI4X0X7BPJ |
UPCMLD-DP133 |
UPCMLD-DP133:001 |
Vioform-Hydrocortisone (Salt/Mix) |
VoSol HC |
VoSol HC (Salt/Mix) |
Vytone |
WI4X0X7BPJ |
Z2786051549 |
Zenoxone |
ZINC13540519 |
US Patents and Regulatory Information for hydrocortisone
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Purepac Pharm | HYDROCORTISONE ACETATE | hydrocortisone acetate | CREAM;TOPICAL | 086052-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Taro | HYDROCORTISONE BUTYRATE | hydrocortisone butyrate | OINTMENT;TOPICAL | 076842-001 | Dec 27, 2004 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Sandoz Inc | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | hydrocortisone; neomycin sulfate; polymyxin b sulfate | SOLUTION/DROPS;OTIC | 062423-001 | Aug 25, 1983 | AT | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Breckenridge | HYDROCORTISONE | hydrocortisone | TABLET;ORAL | 207029-003 | Apr 27, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Barr | HYDROCORTISONE | hydrocortisone | TABLET;ORAL | 083999-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Teligent Pharma Inc | HYDROCORTISONE | hydrocortisone | LOTION;TOPICAL | 203804-001 | Jul 27, 2018 | AT | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Taro | HYDROCORTISONE | hydrocortisone | OINTMENT;TOPICAL | 086257-001 | Approved Prior to Jan 1, 1982 | AT | RX | No | No | Start Trial | Start Trial | Start Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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